BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER

    MDR report key: 23639472 · Received November 24, 2025

    Report

    Report Number
    3015053858-2025-00144
    Event Type
    Death
    Date Received
    November 24, 2025
    Date of Event
    October 19, 2024
    Report Date
    December 9, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC
    Product Code
    QMG
    PMA / PMN Number
    P200039/S008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SHOCKWAVE MEDICAL, INC. THEREFORE, A PHYSICAL EXAMINATION CANNOT BE PERFORMED. THE CAUSE OF THE MYOCARDIAL INFRACTION, UNPLANNED REVASCULARIZATION, AND SUBSEQUENT PATIENT DEATH COULD NOT BE DEFINITIVELY DETERMINED BASED ON THE INFORMATION AVAILABLE. THERE WAS NO IVL DEVICE MALFUNCTION REPORTED. PER THE REPORTER, THE RELATIONSHIP OF THE REVASCULARIZATION PROCEDURE TO THE STUDY DEVICE AND STUDY PROCEDURE ARE BOTH POSSIBLE. A REVIEW OF THE EVENT BY SHOCKWAVE SAFETY DETERMINED THAT THE REPORTED EVENTS WERE NOT RELATED TO THE DEVICE OR PROCEDURE. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. THEREFORE, REVIEW OF THE DEVICE MANUFACTURING AND TEST DOCUMENTATION COULD NOT BE COMPLETED. HOWEVER, SHOCKWAVE MEDICAL, INC. HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING CORRECTIONS WERE MADE TO SECTION B5 PER NEW INFORMATION RECEIVED 24NOV2025: 1. DATE OF THE NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI) HAS BEEN CORRECTED FROM (B)(6) 2024 TO (B)(6) 2024. 2. THIS EVENT WAS SUCCESSFULLY RESOLVED ON THE SAME DAY WITH AN UNPLANNED REVASCULARIZATION PROCEDURE INSTEAD OF THE NEXT DAY.

    Description of Event or Problem · 0

    THE FOLLOWING EVENTS WERE REPORTED FROM THE SHOCKWAVE POST MARKET EMPOWER CAD STUDY. THE SUBJECT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) ON (B)(6) 2024 FOR CORONARY ARTERY DISEASE WITH UNSTABLE ANGINA. TWO SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETERS WERE USED FOLLOWING PRIOR DIAGNOSTIC CATHETERIZATION REVEALING EVIDENCE OF CALCIFICATION. TWO TARGET LESIONS IN THE 1ST DIAGONAL BRANCH AND PROXIMAL LEFT ANTERIOR DESCENDING (LAD) WERE TREATED VIA FEMORAL ACCESS WITH A 6F GUIDE CATHETER. THE 1ST SHOCKWAVE C2+ IVL CATHETER (3015053858-2025-00143) USED SUCCESSFULLY DELIVERED 40 PULSES AND THE 2ND SHOCKWAVE C2+ IVL CATHETER USED SUCCESSFULLY DELIVERED 80 PULSES. MULTIPLE NON-SHOCKWAVE BALLOONS WERE USED DURING THE PROCEDURE FOR PRE AND POST DILATATION. A DRUG ELUTING STENT (DES) WAS PLACED IN EACH OF THE TARGET LESIONS FOLLOWING IVL TREATMENT. ONE (1) DAY POST-INDEX PROCEDURE, THE PATIENT EXPERIENCED CREATINE KINASE-MYOCARDIAL BAND (CKMB) LEVELS OUT OF RANGE, DETERMINED BY THE SITE TO BE UNRELATED TO THE DEVICE AND PROCEDURE. THE 30D ROUTINE FOLLOW-UP WAS UNEVENTFUL. ON (B)(6) 2024, THE PATIENT PRESENTED AT THE HOSPITAL WITH NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI) DETERMINED BY THE SITE TO BE POSSIBLY RELATED TO THE DEVICE AND PROCEDURE. TREATMENT OF THE EVENT INCLUDED TICAGRELOR. THIS EVENT WAS SUCCESSFULLY RESOLVED ON THE NEXT DAY WITH AN UNPLANNED REVASCULARIZATION PROCEDURE. ON (B)(6) 2024, THE PATIENT WAS REPORTED TO HAVE PASSED AWAY BY HER SON, SON DUE TO A NON-CARDIAC CAUSE OF DEATH, DETERMINED BY THE SITE TO BE UNRELATED TO THE DEVICE OR PROCEDURE. AN AUTOPSY WAS NOT PERFORMED. THE EVENT WAS SENT TO THE CLINICAL EVENTS COMMITTEE (CEC) FOR ADJUDICATION OF THE PATIENT'S MI AND SUBSEQUENT DEATH. THE CEC DETERMINED THAT THE PATIENT'S CKMB LEVELS DID NOT EXCEED 5 TIMES THE UPPER LIMIT OF NORMAL (ULN), SO IT WAS NOT CONSIDERED AS A MI EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE PATIENT PRESENTED AT THE HOSPITAL WITH NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI) DETERMINED BY THE SITE TO BE POSSIBLY RELATED TO THE DEVICE AND PROCEDURE. THIS EVENT WAS SUCCESSFULLY RESOLVED ON THE SAME DAY WITH AN UNPLANNED REVASCULARIZATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309433 SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2+ CORONARY IVL CATHETER QMG SHOCKWAVE MEDICAL, INC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization| L| R| D POST-DILATATION - 3.50 X 12MM - ABOTT| POST-STENT DILATATION - 3.00 X 12MM - UNKNOWN MFR| POST-STENT DILATATION - 3.00 X 15MM - UNKNOWN MFR| POST-STENT DILATATION - 3.50 X 12MM - UNKNOWN MFR| POST-STENT DILATATION - 4.00 X 12MM - UNKNOWN MFR| POST-STENT DILATATION - 4.50 X 8MM - UNKOWN MFR| PRE-DILATATION - 2.50 X 12MM - ABOTT| PRE-DILATATION - 3.00 X 12MM - ABOTT| PRE-DILATATION - 3.00 X 15MM - ABOTT| PRE-DILATATION BALLOON - 2.50 X 12MM - ABBOTT